Good Clinical Practices Question and Answer Guide 2005

- $39.95

Expanded and Updated for 2005!
The Good Clinical Practice: A Question & Answer Reference Guide 2005

Developed with input from over 100 industry and government clinical trial and GCP experts, this new reference guide answers close to 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drug, biologics, and device trials.

This leading reference pocket guide has been expanded and updated for 2005 to address, among other areas, emerging financial disclosure standards for clinical research, GCP-related standards for pharmacogenetics testing, and new trends in FDA GCP compliance.

In one pocket handbook, you'll have the authoritative answers to hundreds of common and emerging questions, in 20 GCP-related areas, right at your fingertips:

  • FDA and ICH GCP Standards for Clinical Research
  • Form FDA 1572-Statement of Investigator
  • Informed Consent
  • Patient Recruitment
  • State Standards and GCP
  • Source Data/Documentation
  • Investigator/Site Requirements
  • Clinical Monitoring
  • Clinical Study Safety Reporting
  • Clinical Trial Protocols/Protocol Changes/Protocol Violations
  • Institutional Review Boards
  • Quality Assurance Activities/Study Auditing/FDA Inspections
  • Investigational Drug Accountability, Administration, and Labeling
  • Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!

"We believe that Good Clinical Practice: A Question & Answer Reference Guide is the most important advance in clinical research education in quite some time. This is truly a valuable tool that I recommend every clinical research professional have on their desk."
Lisa Zimmerman, MS Director of QA and Regulatory Compliance Duke Clinical Research Institute

"This is an excellent book--in fact, we thought it was so good that we have obtained copies for all our clinical auditors!"
Ralph Monaghan, BA(Mod) U.S. GCP Audit Director Serono, Inc.

"This new reference takes takes all the key areas of uncertainty in GCP interpretation and implementation that we all struggle with and deals with them head on. It should quickly become the GCP reference of choice in the pharma and biotech industries!"
David Hallinan, Ph.D. Vice President, Regulatory Affairs Idenix Pharmaceuticals

"A reference that goes well beyond a didactic of the regulations to provide informed, practical analysis and advice on both long-discussed as well as important emerging GCP-related issues. An excellent resource for both novice and advanced-level professionals who are actively involved in clinical investigations."
Joy Littlejohn Regulatory Auditor Alexion Pharmaceuticals, Inc.

"A unique, scenario-based approach that addresses the most important and difficult GCP-related issues and gray areas that we all confront on a daily basis. An extremely useful text that uses a question-and-answer format to explore the depths and breadth of GCP standards. Already a leader among GCP references and one that offers an immediate return for readers."
William Hirschhorn Director, Office of Clinical Trials and Research Quality Improvement Temple University  

"This book is excellent. It is comprehensive, authoritative, readable and easy to dip into... Unless you already know all there is to know about GCP, we recommend that you buy this book."
Graeme Scott, Anjo Strik & Jean Saint-Pierre, The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals

May 2005, 499 pp., 1-882615-74-3$39.95